Comparison of the Effectiveness of the "Integrated Intervention for Codependent Individuals" and "Community Reinforcement and Family Training (CRAFT)" in reducing codependency among parents of individuals with substance use disorders
Comparison of the Effectiveness of the "Integrated Intervention for Codependent Individuals" and "Community Reinforcement and Family Training (CRAFT)" in Improving the Level of Codependency among Parents of Individuals with substance use disorder
Design
A block-randomized clinical trial was conducted with two arms, each containing 15 participants (30 participants in total). Block randomization was performed using the SealedEnvelope website. After providing informed consent, each participant randomly selected one of the sealed envelopes and was assigned to the corresponding group.
Settings and conduct
Study location: Addiction Clinic, Roozbeh Hospital, Tehran; Study population: Mothers of individuals who use substances; Blinding method: In this study, blinding was not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a child who uses narcotic drugs and/or stimulants; obtaining a minimum score of 52.6 on the Spann–Fischer Scale; completion of the informed consent form for participation in the study.
Exclusion criteria: Presence of cognitive disorders; severe physical illness that prevents participation in the sessions; illiteracy
Intervention groups
Intervention Group: Integrated Intervention for Codependent Individuals.
Participants receive an integrated treatment program for codependency, consisting of 11 structured sessions.
Control Group: Community Reinforcement and Family Training.
Participants receive the standard CRAFT program
Main outcome variables
Level of codependency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250809066792N1
Registration date:2025-10-03, 1404/07/11
Registration timing:prospective
Last update:2025-10-03, 1404/07/11
Update count:0
Registration date
2025-10-03, 1404/07/11
Registrant information
Name
Fateme Sadat Sadat hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7746 5416
Email address
f-sadathosseini@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-06, 1404/07/14
Expected recruitment end date
2025-12-20, 1404/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of the "Integrated Intervention for Codependent Individuals" and "Community Reinforcement and Family Training (CRAFT)" in reducing codependency among parents of individuals with substance use disorders
Public title
The effectiveness of psychosocial interventions on codependency of mothers of individuals with substance use disorders
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child who uses narcotic drugs and/or stimulants;
Obtaining a minimum score of 52.6 on the Spann–Fischer Codependency Scale
Exclusion criteria:
Lifetime diagnosis of a substance use disorder (based on DSM-5 criteria) according to the participant’s self-report
Presence of severe cognitive disorders as determined by the assessor
Illiteracy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were assigned to two intervention and control groups using a block randomization method with block sizes of 4 and 6, through the website www.sealedenvelope.com.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ebne sina Street; Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2023-05-12, 1402/02/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.096
Health conditions studied
1
Description of health condition studied
Codependency
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life
Timepoint
At study entry, at the third session, and at the end of the study
Method of measurement
World Health Organization Quality of Life – Brief Questionnaire (WHOQOL-BREF)
2
Description
Codependency level
Timepoint
At study entry, at the third session, and at the end of the study
Method of measurement
Spann-Fischer Codependency Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Integrated Intervention for Codependent Individuals.Participants in the intervention group receive an integrated treatment program for codependency, consisting of 11 structured sessions, each lasting 60–90 minutes. Sessions are conducted weekly or twice a week. The topics of these sessions include: taking a clinical history, motivational interviewing, understanding addiction and maladaptive patterns, codependent roles, breaking dysfunctional family cycles, attention to comorbid disorders, problem-solving, and emotion regulation.
Category
Lifestyle
2
Description
Control Group: Community Reinforcement and Family Training(CRAFT).Participants in the control group receive the standard Community Reinforcement and Family Training program, consisting of 10 sessions, each lasting 60–90 minutes, conducted once a week. The program focuses on family education and social reinforcement strategies.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Fatemeh Sadat Hosseini
Street address
South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
hosp_roozbeh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Kordi
Street address
Intersection of Qods Street and Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hosseini
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
South Kargar
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
f-sadathosseini@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Farhoodian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Befor Qazvin Square, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 911 151 7707
Email
farhoudian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hosseini
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Befor Qazvin Square, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
f-sadathosseini@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available